Phase II randomized clinical trial of Pazopanib alone and Pazopanib plus Gemcitabine in relapsed or metastatic soft tissue sarcoma

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.Histologically or cytological confirmed malignant soft tissue sarcoma including any subtypes except:
oChondrosarcoma
oOsteosarcoma
oEwing tumors and primitive neuroectodermal tumors
oGastrointestinal stromal tumors
oDermofibromatosis sarcoma protuberans
oInflammatory myofibroblastic sarcoma
oMalignant mesothelioma
oMixed mesodermal tumors of the uterus
2.Patient must have received at least one prior chemotherapy including either an antrazyclin or ifosfamide or both.
3.ECOG performance status 0-2
4.At least 18 years old
5.Life expectancy > 3 months
6.Patients with at least one measurable lesion according to RECIST criteria (v1.1)
7.Able to swallow and retain oral medication
8.Adequate organ function as defined in protocol
9.A female is eligible to enter and participate in this study if she is either of non childbearing potential (defined in protocol) or childbearing potential with negativ pregnancy test within 2 weeks prior to the first dose of study and agrees to use adequate contraception (as defined in protocol)
10.Signed, written informed consent, willingness to comply with the protocol
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 81
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

Exclusion Criteria

1.Patient has received prior treatment with any anti angiogenic drug (including bevacizumab and tyrosine kinase inhibitors)
2.Active malignancy or any malignancy in the last 5 years prior to first dose of study drug other than STS.
3.History of clinical evidence of CNS metastases or leptomeningeal carcinomatosis (more information see protocol)
4.Clinically significant gastrointestinal disorders/ abnormalities (defined in protocol)
5.Poorly controlled hypertension (defined in protocol)
6.Prolongation of corrected QT interval (QTc) > 480msec
7.Clinically significant cardiovascular disease, for example Cerebrovascular accident, myocardial infarction (equal or lower than 6 months before treatment start), unstable angina, NYHA Class II CHF, arrhythmia requiring medication
8.Major surgery or trauma within 28 days or any non- healing wound, fracture or ulcer
9.Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to Pazopanib or Gemcitabine
10.Presence of uncontrolled infection
11.Women who are pregnant or breast feeding
12.Treatment with any other cancer therapies within 14 days prior to the first dose of study drug (defined in protocol)
13.Evidence of active bleeding or bleeding diathesis
14.Hemoptysis in excess of 2.5 mL (or one half teaspoon) within 8 weeks of first dose of study drug.
15.Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
16.Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study procedures
17.History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months
18.Unable or unwilling to discontinue use of prohibited medications listed in the protocol for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study
19.Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia.